DE102024106456A1 - Plant for processing pharmaceutical containers and method for operating a plant - Google Patents

Abstract

The present invention relates to a system (100) for processing pharmaceutical containers (102), comprising at least one processing station (138) for processing the containers (102), which comprises one of the following: a weighing station, a filling station, a closing station, and/or a control station; a transport device (112) for the containers (102); and a sterilization device (128) which is arranged upstream of the at least one processing station (138) with respect to a transport direction (113) for the containers (102) and has an illumination device (130) with at least one luminous element (132) for emitting UV light, with which the containers (102) can be sterilized. Furthermore, the present invention relates to a method.

Description

The present invention relates to a plant for processing pharmaceutical containers, comprising at least one processing station for processing the containers, which comprises one of the set of weighing station, filling station, closing station and/or control station.

Furthermore, the present invention relates to a method for operating such a system.

Such a facility can process pharmaceutical containers, such as vials, syringes, cartridges, or ampoules. The containers can be rigid or non-rigid.

Typically, the containers are sterilized before being fed into the processing line. Continuously operating cleaning devices are used, where the containers are wet-cleaned and then dried. Cleaning and drying are followed by sterilization. The drying and sterilization steps are carried out, for example, in a sterilization tunnel. Such tunnel dryers have proven effective in practice. However, such tunnel dryers require considerable installation space and a significant amount of energy. Furthermore, it should be noted that loading a sterilization tunnel before production begins takes a considerable amount of time (e.g., one to two hours).

Sterilization tunnels have the disadvantage that they cannot be used to sterilize containers made of plastic materials, which requires the use of a different sterilization process. Sterilization using gamma radiation or electron beam sterilization is conceivable, for example. Media-based sterilization, such as ethylene oxide, is also known. Such sterilization processes are technically complex. In addition, high safety standards must be maintained.

When sterilizing glass containers using a sterilization tunnel, the containers are transferred into the tunnel immediately after cleaning. This can cause mechanical stress on the containers. Glass-to-glass contact can result in scratches, even minor ones, on the containers. If damage to the containers is discovered during inspection, at least the already filled containers must be discarded; in the worst case, the entire production batch. This not only results in production delays but also leads to increased production costs.

Non-stable containers must first be placed in suitable holders for loading during transport through the tunnel. After passing through the tunnel, the containers must be unloaded again, which is complex from a production perspective, as a loading and unloading unit is required. The holders limit the choice of sterilization methods. The holders may come into contact with the containers, partially covering their surfaces, and the sterilization result may be compromised.

After sterilization, the containers are transferred to production, where they can be weighed, filled, reweighed, sealed, inspected, and packaged at the processing stations. Additionally, gassing may be required for oxygen-sensitive products (e.g., pre- and post-gassing).

The object of the present invention is to provide a system for processing pharmaceutical containers in which sterilized containers can be processed with the least possible manufacturing and production expenditure.

This object is achieved by a system according to the invention for processing pharmaceutical containers, comprising at least one processing station for processing the containers, which comprises one of the group consisting of a weighing station, a filling station, a closing station and/or a control station, a transport device for the containers and a sterilization device which is arranged upstream of the at least one processing station with respect to a transport direction for the containers and has an illumination device with at least one luminous element for emitting UV light, via which the containers can be sterilized.

The present invention is based on the consideration that UV sterilization is associated with low manufacturing costs compared to existing sterilization tunnels. In particular, it is preferably possible to sterilize objects not only made of glass, but also made of plastic. The containers can be moved, in particular, relative to the lighting device via the transport device. A continuous or cyclic movement is conceivable, for example. Preferably, the system can dispense with loading and unloading units as in conventional systems. Set-up times, such as loading times for sterilization tion tunnels, where thousands of containers may well have to be pre-loaded, can be kept to a minimum. The set-up time in the system according to the invention is advantageously considerably shorter due to the comparatively fewer containers in the sterilization process and is, for example, in the range of minutes. Time losses due to downtime are eliminated by the invention. Unlike sterilization tunnels, the system according to the invention requires the buffering of relatively few containers during the sterilization process. In the event of a malfunction, the number of containers that are discarded is therefore low compared to conventional systems. Sterilization using UV light (preferably UV-C light) can be carried out in a contact-free manner. This makes it possible to avoid mechanical stress on the containers and reduce the risk of damage. Another advantage compared to sterilization tunnels is that any damage resulting from temperature-related stress can be avoided.

A preferred embodiment of the system according to the invention is characterized by a timed and/or continuous operation of the sterilization device during operation of the at least one processing station. In particular, this provides the possibility of a continuous process in which newly added containers can be continuously sterilized during the processing of already sterilized containers. The transport can be continuous or timed.

It proves particularly advantageous if the system comprises a container cleaning device arranged upstream of the sterilization device in the transport direction of the containers, said device having a washing device and/or a drying device. Before sterilization using UV light, the containers can be washed and/or dried. External and internal cleaning of the containers is particularly conceivable, with all surfaces of the containers exposed if possible, but in particular those surfaces of the containers that come into contact with the product to be filled. The transport device along the washing device and/or the drying device can be designed in any desired manner, for example as a rotary conveyor and/or a linear conveyor.

For example, a washing and drying facility may not be required if already cleaned, non-sterile objects are delivered.

The cleaning device can, for example, comprise an immersion bath through which the containers are passed. The immersion bath contains a cleaning fluid, which can preferably be used for external and internal cleaning.

The cleaning device may, for example, comprise a _CO2 snow cleaning station for cleaning the containers.

For cleaning purposes, it is advantageous if the containers can be changed in terms of their position and/or orientation to ensure they are exposed to the cleaning medium as completely as possible. For example, rotation and/or turning and/or translational movement are conceivable.

The washing device of the cleaning apparatus advantageously comprises a rotating and/or turning station for rotating and/or turning the containers, which can be arranged, in particular, on or in the immersion bath. Alternatively or additionally, a station for translational movement can be provided, in particular, on or in the immersion bath.

For example, a station for ultrasonic cleaning of the containers can be arranged on or in the immersion bath.

The drying device of the cleaning device can be designed in different ways. For example, the drying device includes a blow-out device for the containers. In this case, a nozzle element or blower element is inserted into the respective container and the container is pressurized with gas on its inside. "Gas" in this context can also be understood as a gas mixture such as air.

The drying device of the cleaning device may preferably comprise a blow-off device for the containers, wherein the containers are blown off on the outside.

A rotating and/or turning station for rotating and/or turning the containers during blowing, blowing off, and/or heating is conceivable. Alternatively or additionally, a station for translational movement can be provided.

Advantageously, the drying device of the cleaning device comprises a heating device for the containers so that they can be dried by heating.

The heating device comprises, for example, a heating element that can be inserted into the container. Alternatively or additionally, one or more heating elements can be arranged on the outside of the container. The use of a heatable Chamber through which the containers are transported.

Advantageously, the system is free of a sterilization tunnel for the cleaned containers. This allows for a simplified design of the system.

The system may, for example, comprise at least one frame on which the cleaning device, the sterilization device and/or the at least one processing station is/are positioned.

Furthermore, the system may include at least one isolator device covering the cleaning device, the at least one processing station, and/or the sterilization device. An "isolator device" in this case may be considered a containment, a protective device for air purity, which may be or include an isolator or a RABS (restricted access barrier system).

A preferred system according to the invention is characterized by a higher purity class of the system in the area of the at least one processing station and the sterilization device than in the area of the cleaning device.

For example, the cleaning device is located in a room with GMP cleanliness class B, C, D, or NC (GMP, Good Manufacturing Practice). After cleaning and drying the containers, the containers are transferred, for example, to a room with GMP cleanliness class A, in which, in particular, the sterilization device and the at least one processing station are located. For the above purpose, it may be advantageous to have a separate isolator device covering the sterilization device and the at least one processing station. If necessary, an isolator device covering the cleaning device can be omitted.

Before the production process, a cleanroom containing the sterilization device and at least one processing station is typically raised to a GMP cleanroom level A. For this purpose, the cleanroom is closed, and, for example, a decontamination process _{with H2O2} is carried out in a conventional manner. Increasing the pressure in the cleanroom advantageously ensures that the decontamination atmosphere flows from a higher cleanroom level (especially A) into a lower cleanroom level (e.g., B, C, D, or NC) and/or that media exchange between the rooms is prevented or reduced to a minimum.

The at least one luminous element is preferably designed to emit UV-C light. This enables reliable sterilization of the containers.

For example, light within the wavelength range from approximately 100 nm to approximately 300 nm can be emitted by at least one luminous element, although longer wavelengths in the UV range are also conceivable.

It can be provided that the at least one luminous element can emit UV light in continuous operation and/or pulsed operation. Conveniently, it is possible to switch between continuous operation and pulsed operation.

Preferably, a luminous intensity and/or luminous duration of the at least one luminous element can be controllable and/or regulated.

The containers can advantageously be exposed to UV light (and in particular UV-C light) on the outside and/or inside via at least one luminous element.

The at least one lighting element can be designed, for example, as an LED module or as a fluorescent tube.

The containers can be exposed to UV light (and in particular UV-C light) individually or in groups of two or more containers, for example, via the at least one luminous element.

Advantageously, two or more luminous elements are provided. The luminous elements can be identical or different in design. Two or more luminous elements can have identical wavelength ranges of emitted light and/or two or more luminous elements can have different wavelength ranges of emitted light.

• - mindestens ein Transportrad zum umlaufenden Transport der Behälter;
• - mindestens einen linearen Transport zum geradlinigen Transport der Behälter;
• - mindestens ein Band, auf dem die Behälter stehend transportierbar sind;
• - mindestens einen Rechentransport;
• - mindestens eine robotische Vorrichtung;
• - mindestens ein Planarmotorantriebssystem;
• - mindestens ein Halteteil zum hängenden Transport der Behälter.

The transport device may, for example, comprise or form at least one for transporting the containers:

• - at least one transport wheel for the circulating transport of the containers;
• - at least one linear transport for the straight transport of the containers;
• - at least one belt on which the containers can be transported upright;
• - at least one rake transport;
• - at least one robotic device;
• - at least one planar motor drive system;
• - at least one holding part for hanging transport of the containers.

For example, the transport device comprises format parts whose design is adapted to the containers to be processed. The transport device can have two or more format sets with respective format parts, whereby the format parts of different format sets differ from one another with regard to at least one container-specific property. The use of format parts can minimize system downtime. Format changes can be performed manually and/or without tools. Alternatively or additionally, a mechanical format change is conceivable, for example, using a robotic device.

Advantageously, the transport device can be designed without format parts, so that a format change can be omitted.

For picking up and/or holding the containers, the transport device can comprise, for example, holding parts, tongs, grippers, etc., which can preferably be format parts.

The transport device is advantageously designed in such a way that the respective container can be exposed to UV light, preferably on the outside and/or inside, in such a way that the container can be sterilized as completely as possible.

Advantageously, the transport device can be sterilized using UV light.

The sterilization device can preferably, in particular to achieve the aforementioned purpose, comprise a turning station, a rotating station, and/or a station for a translational movement of the containers relative to the at least one luminous element. The respective station can be configured to be active or passive.

Alternatively or additionally, to achieve the aforementioned purpose, the sterilization device can, for example, comprise at least one drive element for acting on at least one luminous element and/or at least one container with respect to a relative movement of the at least one container and the at least one luminous element. This enables, for example, a rotation, pivoting, turning, and/or translational movement of the container and/or the luminous element. The movement can be performed before or during the illumination of the container with UV light.

It can be provided that the at least one lighting element is stationary and that the containers are movable relative to the at least one lighting element via the transport device and/or by means of the at least one drive element.

The containers can be transported continuously or in a timed manner, for example, using the transport device.

It is conceivable, for example, that at least one luminous element is held on a luminous element carrier, which can be inserted into and removed from the container by means of the at least one drive element, for exposing the container's interior to UV light. The luminous element carrier is, for example, needle-shaped and provided with at least one luminous element at or near one end.

A plurality of light-emitting element carriers can be provided, with each light-emitting element carrier being insertable into a respective container. This enables, for example, synchronized sterilization of the containers.

Depending on the type of container being processed, inserting a light-emitting element into the container may be unnecessary. Containers made of UV-transparent material, for example, can also be sterilized internally by illuminating them from the outside.

The sterilization device can, for example, comprise at least one chamber through which the transport device runs, wherein at least one luminous element, preferably a plurality of luminous elements, is arranged in the chamber, wherein the containers can be transported through the chamber with at least one deflection. For example, the transport device is designed such that the containers are transported through the chamber along a path with one or more deflections. The path can, for example, be designed in a chicane-shaped or meandering manner. Advantageously, the transport device is at least partially transparent to UV light, and in particular UV-C light, in order to enable irradiation over as full a surface as possible.

Two or more chambers are conceivable as described above and below.

The walls of the chamber can be fully or partially mirrored to reflect UV light.

To protect the environment, UV light can be shielded at the inlet and/or outlet of the chamber. This shielding can be achieved, for example, by means of a suitable cover element at an inlet and/or outlet.

Ideally, the objects are guided past one or more luminous elements during transport through the chamber, exposing every surface of the container, if possible. A luminous element carrier may be inserted into the respective container for internal sterilization, as described above.

It can be advantageous if the containers can be transported along a meander through the chamber.

The transport device can, for example, run between two or more lighting elements at one or more sections in the chamber, which makes it possible, for example, to irradiate from two sides.

For example, at least one lighting element can be arranged between two sections of the transport device in the chamber. The lighting element can preferably illuminate containers on both sides located at the respective section.

The transport device can, for example, run through the chamber in two or more superimposed levels, with at least one lighting element being arranged in each level.

It can be provided that the containers can be sterilized during transport by the transport device. Alternatively, it is conceivable that the containers can be removed from the transport device for sterilization by means of a handling device and then reinserted into the transport device. This enables, for example, continuous, timed sterilization.

In a preferred embodiment of the invention, the sterilization device can comprise at least one chamber in which at least one luminous element is arranged, wherein at least one container can be inserted into the at least one chamber, sterilized in the chamber using UV light, and subsequently removed from the chamber. Preferably, there are several chambers, each of which can accommodate at least one container.

In the last-mentioned embodiment, the containers can be decoupled from the transport device, for example, via a handling device and transferred into the at least one chamber.

In contrast, the at least one chamber can, for example, be constructed around the transport device, so that the containers moved by means of the transport device are sterilized during transport through the at least one chamber.

The transport can, for example, be carried out in a timed manner by a rake transport or by means of a robot within at least one chamber.

This results in the at least one container being movable, for example, into and out of the at least one chamber by means of the transport device. Alternatively, the at least one container can be uncoupled from the transport device by means of a handling device and inserted into the at least one chamber, as well as being movable out of the at least one chamber via the handling device and coupled into the transport device for further transport.

The at least one chamber can be designed to reflect UV light on the inside.

By using at least one chamber, the space to be sterilized can be kept small, thereby saving energy and time.

The sterilization device can, for example, comprise two or more chambers arranged one behind the other in the transport direction, which can preferably each be equipped with at least one container simultaneously.

When using two or more chambers, an air flow is advantageously provided from an area of higher purity to an area of lower purity in order to avoid possible particle entrainment towards the area of higher purity.

The two or more chambers can be positioned side by side or one above the other, for example. The aforementioned air flow can be vertical and/or horizontal, for example.

The use of multiple chambers makes it possible, for example, to sterilize containers step by step. If the chambers are in the transport For example, if the containers are arranged one behind the other in a row, they are first sterilized in the first chamber. The container can then be transported further into the next chamber and sterilized there. This ensures a high level of process reliability.

It may be advantageous if the at least one chamber can be sterilized after a predetermined number of sterilization processes without the container being accommodated therein. This increases process reliability, for example, preventing the carryover of non-sterile particles. Sterilizing the chamber without the container being accommodated preferably enables sterilization of holding parts within the chamber.

The sterilization device can preferably be constructed in multiple stages with a plurality of sterilization stages arranged one behind the other in the transport direction, with at least one luminous element being arranged in each sterilization stage. Preferably, the sterilization stages have an increasing degree of purity in the transport direction and/or at least one separating element is present between successive sterilization stages. The individual sterilization stages can, for example, be arranged in successive chambers, with the separating element separating the chambers from one another and being selectively open or closed.

The multiple sterilization stages may include different types of sterilization, for example by means of UV light, by means of gamma radiation, by means of electron beam sterilization, by means of ethylene oxide and/or H ₂ O ₂ .

It has already been mentioned that the system may comprise an isolator device for decontamination by means of a gas, in particular H ₂ O ₂ . The sterilization device can preferably be decontaminated by such a device before a production cycle.

It is understood that the system may comprise a control device for controlling and/or regulating the operation.

The user interface is preferably an intuitive HMI (Human Machine Interface).

The sterilization device may comprise a sensor device for determining the cleanliness level of the containers during or after the sterilization process. The sterilization device may, for example, be controllable and/or adjustable depending on a signal from the sensor device.

As mentioned at the beginning, the present invention also relates to a method.

A method according to the invention for operating a system of the type described above provides that the containers are sterilized via the sterilization device by means of irradiation with UV light before being fed to at least one processing station.

The advantages already mentioned in connection with the explanation of the system according to the invention can also be achieved by implementing the method. Advantageous embodiments of the method according to the invention result from advantageous embodiments of the system according to the invention. Reference can be made to the above explanations in each case.

• 1: eine schematische Darstellung der erfindungsgemäßen Anlage in bevorzugter Ausführungsform, wobei 1 auch den Prozess zum Verarbeiten von pharmazeutischen Behältern verdeutlicht;
• 2: eine vergrößerte Darstellung von Detail A in 1 bei einer beispielhaften Ausführungsform;
• 3: eine schematische Darstellung einer Wascheinrichtung einer Reinigungsvorrichtung der Anlage aus 1;
• 4 und 5: schematische Darstellungen von Trocknungseinrichtungen einer Reinigungsvorrichtung der Anlage aus 1;
• 6: eine schematische Darstellung einer Sterilisationsvorrichtung der Anlage aus 1;
• 7 bis 11: schematische Darstellungen einer Sterilisationsvorrichtung der Anlage aus 1 zu unterschiedlichen Zeitpunkten;
• 12 bis 15: schematische Teildarstellungen einer Sterilisationsvorrichtung der Anlage aus 1 zu unterschiedlichen Zeitpunkten; und
• 16 bis 19: Darstellungen ähnlich den 12 bis 15 bei einer andersartigen Sterilisationsvorrichtung der Anlage.

The following description of preferred embodiments of the invention, taken in conjunction with the drawings, serves to explain the invention in more detail. They show:

• 1 : a schematic representation of the system according to the invention in a preferred embodiment, wherein 1 also illustrates the process for processing pharmaceutical containers;
• 2 : an enlarged view of detail A in 1 in an exemplary embodiment;
• 3 : a schematic representation of a washing device of a cleaning device of the system from 1 ;
• 4 and 5 : schematic representations of drying devices of a cleaning device of the plant from 1 ;
• 6 : a schematic representation of a sterilization device of the plant from 1 ;
• 7 to 11 : schematic representations of a sterilization device of the plant from 1 at different times;
• 12 to 15 : schematic partial representations of a sterilization device of the plant from 1 at different times; and
• 16 to 19 : Representations similar to the 12 to 15 with a different type of sterilization device in the system.

1 shows a schematic representation of an advantageous embodiment of the inventive device, designated overall by the reference numeral 100 System for processing pharmaceutical containers. The containers designated with reference numeral 102 in the drawing can be designed in different ways. For example, these are vials 104, as in the application examples of the 12 to 19 Alternatively or additionally, the containers 102 may be syringes, cartridges, or ampoules.

1 In addition to the schematic design of the system 100, it also represents successive work steps, with arrows 106 symbolizing the sequence of work steps.

First, the containers 102 of the system 100 are transferred to a transfer area 110 in a transfer step 108. Depending on the nature of the containers 102, the transfer step 108 can vary. Bulk containers can be coupled in via a turntable, for example. Nested objects can be lifted out of a carrier held in a tub or tray. This can be done automatically, for example, using a robotic device.

Conveniently, the containers 102 are transferred continuously.

For transporting the containers 102, the system 100 comprises a transport device 112, which can be configured differently, for example, depending on the work step. The transport device 112 can, for example, comprise at least one rotary conveyor, at least one linear conveyor, at least one rake conveyor, at least one robotic device, and/or at least one holding element for suspended transport of containers 102, in particular non-stable containers. The transport device 112 can be configured for continuous transport and/or operate in a timed manner.

Exemplary embodiments of the transport device 112 or individual sections thereof are described below.

The reference numeral 113 indicates a transport direction of the transport device 112.

The transfer step 108 is preferably followed by a cleaning step 114, for which a cleaning device 116 is used. In a washing step 118, using a washing device 120 of the cleaning device 116, the containers 102 are first washed inside and out. In a subsequent drying step 122, using a drying device 124 of the cleaning device 116, the containers 102 are then dried inside and out.

The containers 102 are then subjected to a sterilization step 126 using a sterilization device 128. A lighting device 130 with at least one light element 132 is used. The light element 132 is configured to emit UV light. The containers 102 are sterilized using the UV light.

In particular, the luminous element 132 is designed to emit UV-C light. The UV light can be emitted in continuous or pulsed mode.

As will be explained below, the containers 102 can be exposed to UV light via the at least one luminous element, preferably on the outside and inside.

The lighting element 132 can be designed in different ways, for example flat, point-like, as an LED module or as a fluorescent tube.

The containers can be exposed to UV light, for example individually or in groups, with two or more containers 102, via the lighting element 132.

The lighting can be controlled and/or regulated. It is conceivable to monitor the function of the lighting device 130 to ensure the function of the sterilization device 128 and thus the sterility of the containers 102.

The system 100 preferably comprises a control device 134 for controlling and/or regulating the operation. The control device 134 can be operatively connected to the respective components of the system 100.

The cleaned and sterilized containers 102 are processed in a subsequent processing step 136 at at least one processing station 138 from the group consisting of a weighing station, filling station, closing station and/or inspection station. In particular, several processing stations 138 are provided, wherein 1 Only one station is shown by way of example. The processing station(s) 138 may be of conventional design.

In particular, the system 100 may include a weighing station, a filling station, a closing station and a control station as processing stations 138.

It is advantageous if the system 100 has a high degree of purity, at least in the area of the sterilization device 128 and the processing station 138. In particular, this can be purity level A according to GMP (Good Manufacturing Practice). For this purpose, the system 100 may include an isolator device 140, which, for example, covers a frame 142 with the sterilization device 128 and the processing station 138.

In contrast, at the transfer area 110 and the cleaning device 116, the degree of purity may be lower and may, for example, be purity grade B, C, D or NC according to GMP.

The transfer area 110 and the cleaning device 116 can be arranged on a common frame 142 and optionally covered by an isolator device 140.

In system 100, the containers to be processed are cleaned and sterilized prior to processing, as mentioned above. This can be done continuously and/or intermittently. UV-C-based sterilization allows for a simple design of system 100. Compared to conventional systems, less space is required. In particular, a sterilization tunnel, the requirements of which were described above, can be eliminated. Accordingly, system 100 preferably does not include such a sterilization tunnel.

Before processing the containers 102, the system 100 is raised to GMP cleanliness level A in the area of the sterilization device 128 and the processing station 138. For example, this area of the system 100 is sealed off and a decontamination process is carried out, for example, by evaporating hydrogen peroxide.

Advantageously, a pressure gradient is ensured within the system 100, with the pressure being higher in the area of purity level A than in other areas. Any transport of media thus takes place from the area of higher purity level to the area of lower purity level (for example, in the direction of the cleaning device 116 and at the transfer area 110). This prevents the introduction of particles that could lead to decontamination into the sterilization device 128 and the processing station 138.

3 schematically shows a possible embodiment of the washing device 120 of the cleaning device 116. In the present example, the washing device 120 comprises an immersion bath 144 through which the containers 102 are conveyed by means of the transport device 112. In the immersion bath 144, the containers 102 are cleaned, preferably on the outside and inside, using a cleaning fluid. The cleaning fluid can be water, to which a cleaning chemical can be added to increase the cleaning performance.

For example, a station for ultrasonic cleaning of the containers can be arranged on or in the immersion bath 144.

It may be advantageous if the washing device has at least one station 146 for turning, rotating, and/or translational movement, so that the surfaces of the containers 102 are exposed as much as possible and can be exposed to the cleaning fluid. Accordingly, the station 146 can be a turning station, a rotating station, or a translational movement station.

The washing device 120 can have, for example, a rinsing station 148 as an additional station, with which containers 102 are rinsed inside and/or outside. For cleaning the inside, a nozzle element 150 can be inserted into the respective container 102, for example. Nozzle elements 152 serve, for example, to clean the outside of the containers 102.

To achieve a relative movement between the container 102 or multiple containers 102 and a component of the system 100 processing them (for example, the cleaning device 116, the sterilization device 128, and the processing station 138), one or more drive elements 154 are preferably provided. The drive element 154 can act on the container(s) 102 and/or on the corresponding component of the system 100. Accordingly, the containers 102 can be moved relative to the component, or the component relative to the container 102. It is also conceivable that both the container 102 and the component are moved. This also applies to the components of the system 100 explained below and will not be explained separately there.

3 shows, by way of example, the drive element 154 for moving the nozzle elements 150 relative to the containers 102.

After washing, the containers 102 are transported to the drying device 124. 4 shows a schematic structure of the drying device 124, which includes, for example, heating elements 156. The heating elements 156 can be introduced into the containers 102 by means of the drive element 154 in order to dry the inside. Furthermore, heating elements 156 can be provided on the outside to dry the outer surfaces of the containers 102.

By means of at least one station 146, the containers 104 can be moved, as explained above using the example of the washing device 120.

The drying of the containers 102 can be carried out with a container opening facing downwards or upwards or, depending on the station 146, in a different orientation.

Unlike a sterilization tunnel, in which the containers 104 are dried, sterilized, and depyrogenated, the containers in the drying device 124 are only dried, which saves a considerable amount of time, and are subsequently sterilized using UV light.

In 4 Instead of the heating element 156 or in addition to it, a blowing element 158 can be used, in particular for drying the inside of the containers 102.

A further schematic representation of a drying device 124 is shown in 5 The drying device 124 comprises a chamber 160, which in this case forms a tunnel. The containers 102 are moved through the chamber 160 by means of the transport device 112. A change in position and/or orientation can be made therein, for example, by means of the transport device 112 or a station 146.

Heating elements 156 are arranged in chamber 160 to dry the containers 102 on the outside and inside. Relative movement to chamber 160 serves, in particular, to expose both the outside and inside surfaces to achieve a high degree of drying.

The 3 to 5 show holding parts 162, by means of which the containers 102 are transported in the transport device 112. After drying, it is advantageous if the holding parts 162 remain in the area with the lower purity level B, C, D, or NC. In the area with the higher purity level A, separate holding parts 162 are preferably used to prevent particles from being carried into this area.

6 shows a schematic representation of a preferred embodiment of the sterilization device 128.

The sterilization device 128 comprises or forms a chamber 164 in which a wall 166 encloses an interior space 168. The transport device 112 is guided through the chamber 164, from an inlet 170 to an outlet 172.

The transport device 112 is designed such that a transport path 174, in which containers 102 are guided or along which the containers 102 are transported (for example by means of holding parts 162), has at least one deflection 176.

In the present example, the transport device 112 is designed such that the containers 102 are guided through the chamber 164 along a meander 178. The meander 178 accordingly forms a plurality of deflections 176 on the transport path 174, in this case seven.

The lighting device 130 in the present case comprises a plurality of lighting elements 132. These are arranged such that the containers 102 are moved past the lighting elements 132 and, as a result of the deflections 176, are positioned in different relative positions to the lighting elements 132, whereby the surfaces of the containers 102 are exposed as far as possible to exposure to UV light.

The luminous elements 132 can be configured identically or differently. Two or more luminous elements 132 can have identical wavelength ranges of emitted light and/or two or more luminous elements 132 can have different wavelength ranges of emitted light.

In particular, it is provided that the transport device 112 runs between two or more lighting elements in several sections 180, so that the containers 102 can be exposed to UV light from opposite sides.

Furthermore, it is provided that at least one lighting element 132 is arranged between two sections 180 of the transport device 112 in the chamber 160.

At least one schematically illustrated cover element 182 can be arranged at the inlet 170 and/or at the outlet 172 in order to prevent the escape of UV light from the interior space 168.

As protection from the environment of the chamber 164, a section of the transport device 112 can also be provided with a chicane (for example an S-chicane) or the like.

The 6 shows an embodiment in which the containers 102 are transported in one plane through the chamber 164. It is conceivable that the sterilization device 128 has a plurality of planes in which the containers 102 are transported Floor walls and/or intermediate floors of the chamber 164 can be designed to be transparent to UV light.

The transport device 112 can also be completely or partially transparent to UV light. This is 6 symbolized by a dashed contour 184. In contrast, for example, a solid contour 186 in 6 symbolize an embodiment of the transport device 112 which is not permeable to UV light in order to protect the environment.

Another advantageous embodiment of the sterilization device 128 is shown in the 7 to 11 shown and illustrated in different work steps.

At least one chamber 188 is provided along the transport device 112, with preferably several chambers 188 arranged one behind the other in the transport direction 113 being provided. Four chambers 188 are shown as an example, but their number is not limiting.

At least one lighting element 132 of the lighting device 130 is arranged in each chamber 188.

At least one container 102 can be positioned in each chamber 188 for sterilization purposes. In the present case, the sterilization device 128 is configured to sterilize two containers 102 at a time.

In order to introduce the containers 102 into the chambers 188, the transport device 112 can be designed such that it is capable of moving the containers 102 into and out of the chamber.

Alternatively, a 7 A schematically illustrated handling device 190 may be provided, via which the containers 102 are uncoupled from the transport device 112 and introduced into the chamber 188. After sterilization, the containers 102 are moved out of the chamber 188 again via the handling device 190 and coupled into the transport device 112. The handling device 190 may, for example, be robotic.

For inserting the containers 102 into the chamber 188 and for removing them therefrom, holding parts 192 can be provided, which can be part of a chamber wall.

In the sterilization device 128 according to the 7 to 11 For example, the containers 102 are sterilized step by step. The containers 102 are first introduced into the first chamber 188 in the transport direction 113 (in the 7 and 8 the left chamber 188). Subsequently, the containers 102 are removed from chamber 188 and transported to the next chamber 188. This continues until the containers 102 in all four chambers 188 have been sterilized step by step.

In a different mode of operation of the sterilization device 128, which can preferably be selected selectively, containers 102 are sterilized only once in each chamber 188 and then transported further via the transport device 112. Containers 102 are not transported successively into each of the chambers 188.

The 7 and 8 show how the containers 102 are first inserted into the chambers 188. The 9 then shows the further transport of containers 102. 11 shows how a next pair of containers 102 is picked up.

The 10 The work step shown is optional. It is conceivable that after a predetermined or predeterminable number of sterilization processes of containers 102, a respective chamber 188 is sterilized without a container accommodated therein.

During a step-by-step sterilization of the containers 102 in successive chambers 188, it may be advantageous if the containers 102 change in position and/or orientation within the respective interior of the chamber 188 compared to a previous chamber. For example, the containers 102 are gripped in different ways. For this purpose, suitable holding parts 162, grippers, clips, or the like can be used to release the containers 102 at different locations. Accordingly, the holding parts, clips, or grippers can engage the containers 102 at different points.

It can be provided that in the sterilization device 128 there is an air flow opposite to the transport direction 113, from the "clean" containers 102 to the "dirty" containers 102. This prevents a distribution of contaminating particles in the transport direction 113.

It is advantageous if the chambers 188 are designed to be at least partially reflective to UV light on the inside of walls and/or holding parts, clips, grippers, or the like. Similarly, it is advantageous if the chamber 164 is designed to be fully or partially reflective on the inside.

The 12 to 15 show a preferred embodiment of the sterilization device 128 at different times during the sterilization of a container 102.

In each case, the lighting device 130 is provided with a light-emitting element carrier 194 on which at least one light-emitting element 132 is arranged. In the present case, the light-emitting element 132 is arranged at the end of a needle-shaped light-emitting element carrier 194. By means of the drive element 154, the light-emitting element carrier 194 can be inserted into and withdrawn from the container 102 in order to sterilize the interior surfaces of the container 102. This proves particularly advantageous when the container 102 is made of a material that is impermeable to UV light.

While the 12 to 15 show the container 102 with the container opening arranged at the top, it is understood that the container 102 could be oriented in any space.

The embodiment of the sterilization device 128 according to the 16 to 19 , which in terms of sequence the 12 to 15 The device has a plurality of light elements 132, in this case three, on the light element carrier 194. For example, with a suitable arrangement of the light elements 132, this allows for even more targeted illumination of critical areas, such as the neck area of vials 104.

The sterilization device 128 may include a plurality of light-emitting element carriers 194, allowing a plurality of containers 102 to be sterilized simultaneously. This may be performed, for example, in a synchronized mode.

Sterilization of containers 102 using the light element carriers 194, as in the 12 to 19 shown, can be used in the embodiments of the 6 to 11 be provided.

Using the example of 7 to 11 , in the optional step in 10 , it was explained that sterilization can be carried out in several stages. Accordingly, sterilization stages 196 arranged one after the other in the transport direction 113 can be provided, through which the containers 102 pass. Preferably, the sterilization stages 196 have an increasing degree of purity in the transport direction.

2 schematically shows a plurality of sterilization stages 196 during the sterilization step 126 (i.e., in this case, there are several individual steps). Separating elements 198 can be arranged between the individual sterilization stages 196 to prevent the spread of particles and/or to ensure that the degree of purity increases in the transport direction 113. The sterilization stages 196 can be functionally designed in different ways. The separating elements 198 can be designed, for example, in the form of bulkheads.

List of reference symbols

100

Attachment

102

container

104

Vial

106

Arrow

108

Handover step

110

Transfer area

112

Transport device

113

Transport direction

114

Cleaning step

116

Cleaning device

118

Washing step

120

Washing facility

122

Drying step

124

Drying device

126

Sterilization step

128

Sterilization device

130

Lighting equipment

132

Lighting element

134

Control device

136

Processing step

138

processing station

140

Isolator device

142

frame

144

Immersion bath

146

station

148

Rinsing station

150, 152

nozzle element

154

drive element

156

heating element

158

Blow element

160, 164, 188

chamber

162, 192

Holding part

166

wall

168

Interior

170

inlet

172

Outlet

174

Transport track

176

redirection

178

meander

180

Section

182

Cover element

184, 186

contour

190

Handling device

194

Light element carrier

196

Sterilization level

198

Separating element

Claims (22)

System (100) for processing pharmaceutical containers (102), comprising at least one processing station (138) for processing the containers (102), which comprises one of the group consisting of a weighing station, a filling station, a closing station and/or a control station, a transport device (112) for the containers (102) and a sterilization device (128) which is arranged upstream of the at least one processing station (138) with respect to a transport direction (113) for the containers (102) and has a lighting device (130) with at least one lighting element (132) for emitting UV light, with which the containers (102) can be sterilized. Annex (100) to Claim 1 , characterized by a clocked and/or continuous operation of the sterilization device (128) during operation of the at least one processing station (138). Annex (100) to Claim 1 or 2 , characterized in that the system (100) comprises a cleaning device (116) for the containers (102) which is arranged upstream of the sterilization device (128) in the transport direction (113) of the containers (102) and which has a washing device (120) and/or a drying device (124). Annex (100) to Claim 3 , characterized in that the cleaning device (116) comprises at least one of the following: - an immersion bath (144) through which the containers (102) are passed; - a CO ₂ snow cleaning station; - a rotating and/or turning station (146) for rotating and/or turning the containers (102), in particular in the immersion bath (144); - a blow-out device for the containers (102); - a blow-off device for the containers (102); - a heating device for the containers (102). Annex (100) to Claim 3 or 4 , characterized in that the system (100) is free of a sterilization tunnel for the cleaned containers (102). System (100) according to one of the preceding claims, characterized in that the system (100) comprises at least one of the following: - at least one frame (142) on which the cleaning device (116), the sterilization device (128) and/or the at least one processing station (138) is positioned; - at least one isolator device (140) covering the cleaning device (116), the at least one processing station (138) and/or the sterilization device (128). Annex (100) according to one of the Claims 3 until 6 , characterized by a higher purity class of the system (100) in the area of the at least one processing station (138) and the sterilization device (128) than in the area of the cleaning device (116). System (100) according to one of the preceding claims, characterized in that at least one of the following applies: - the at least one lighting element (132) is designed to emit UV-C light; - the at least one lighting element (132) is designed to emit UV light in continuous operation and/or in pulsed operation; - the containers (102) can be exposed to UV light on the outside and/or inside via the at least one lighting element (132); - the at least one lighting element (132) is designed to be flat or point-shaped; - the at least one lighting element (132) is designed as an LED module or as a fluorescent tube; - the containers (102) can be exposed to UV light individually or in groups, with two or more containers, via the at least one lighting element (132); - two or more lighting elements (132) are provided. Plant (100) according to one of the preceding claims, characterized in that the transport device (112) comprises or forms at least one of the following for the transport of the containers (102): - at least one transport wheel for the circulating transport of the containers (102); - at least one linear transport for the rectilinear transport of the containers (102); - at least one belt on which the containers (102) can be transported upright; - at least one rake transport; - at least one robotic device; - at least one planar motor drive system; - at least one holding part (162) for suspended transport of the containers (102). Plant (100) according to one of the preceding claims, characterized in that the containers (102) can be transported continuously or in a timed manner by means of the transport device (112). System (100) according to one of the preceding claims, characterized in that the sterilization device (128) comprises a turning station and/or a rotating station for moving the containers (102) relative to the at least one lighting element (132). System (100) according to one of the preceding claims, characterized in that the sterilization device (128) comprises at least one drive element (154) for acting on at least one lighting element (132) and/or at least one container (102) for a relative movement of the at least one container (102) and the at least one lighting element (132). Annex (100) to Claim 12 , characterized in that at least one luminous element (132) is held on a luminous element carrier (194) which can be inserted into and withdrawn from the container (102) by means of the at least one drive element (154), in order to subject the container (102) to UV light on the inside, in particular that a plurality of luminous element carriers (194) are provided which can be inserted into a plurality of containers (102). System (100) according to one of the preceding claims, characterized in that the sterilization device (128) comprises a chamber (164) through which the transport device (112) runs, wherein at least one lighting element (132) is arranged in the chamber (164), preferably a plurality of lighting elements (132), wherein the containers (102) can be transported through the chamber (164) with at least one single deflection (176). Annex (100) to Claim 14 , characterized in that the sterilization device (128) is designed such that at least one of the following applies: - the containers (102) can be transported along a meander (178) through the chamber (164); - the transport device (112) runs between two or more lighting elements (132) at one or more sections (180) in the chamber (164); - at least one lighting element (132) is arranged between two sections (180) of the transport device (112) in the chamber (164); - the transport device (112) runs through the chamber (164) in two or more superimposed planes, wherein at least one lighting element (132) is arranged in each plane. System (100) according to one of the preceding claims, characterized in that the sterilization device (128) comprises at least one chamber (188) in which at least one luminous element (132) is arranged, wherein at least one container (102) can be inserted into the at least one chamber (188), can be sterilized in the chamber (188) by means of UV light and can then be removed again from the chamber (188). Annex (100) to Claim 16 , characterized in that the at least one container (102) can be moved into and out of the chamber (188) by means of the transport device (112) or that the at least one container (102) can be uncoupled from the transport device (112) by means of a handling device (190) and inserted into the at least one chamber (188) and can be moved out of the chamber (188) via the handling device (190) and coupled into the transport device (112). Annex (100) to Claim 16 or 17 , characterized in that the sterilization device (128) comprises two or more chambers (188) arranged one behind the other in the transport direction (113), which can preferably be equipped simultaneously with at least one container (102) each. Annex (100) according to one of the Claims 16 until 18 , characterized in that the at least one chamber (188) can be sterilized after a predetermined number of sterilization processes of containers (102) without a container (102) accommodated therein. System (100) according to one of the preceding claims, characterized in that the sterilization device (128) is constructed in several stages with a plurality of sterilization stages (196) arranged one behind the other in the transport direction (113), wherein at least one lighting element (132) is arranged in each sterilization stage (196), wherein preferably the sterilization stages (196) in the transport direction (113) have an increasing degree of purity and/or at least one separating element (198) is present between successive sterilization stages (196). Annex (100) to Claim 20 , characterized in that the successive sterilization stages (196) are functionally different. Method for operating a system (100) according to one of the preceding claims, wherein the containers (102) are sterilized via the sterilization device (128) by means of irradiation with UV light before being fed to the at least one processing station (138).